This Study Was to Investigate the Efficacy of Fetal Right Heart Doppler Findings in Determination of Pulmonary Maturity

Preterm Birth Clinical Trial

Official title:

Relationship Between Fetal Right Heart Doppler Findings With Lamellar Body and Fetal Lung Maturity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296591
• Other study ID #: EComert
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2020
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Objective: The aim of this study was to investigate the efficacy of fetal right heart doppler findings in determination of pulmonary maturity.

Materials and Methods: Pregnant women refered to the Department of Obstetrics and Gynecology at Karadeniz Technical University were included in the study. Pregnant women with pregestational or gestational diabetes mellitus, morbid obesity, thyroid dysfunction and fetal abnormality aneuploidy were not included in the study. The study was planned on women with late preterm and term pregnancy. Late preterm cases between 34-37 weeks were included in study group and term cases over 37 weeks were in control group. The doppler findings of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main outcomes. During caesarean section, 5cc amniotic fluid was taken to measure lamellar bodies count. Perinatal results of patients were recorded. p<0.05 was considered as statistical significance.

Description:

MATERIAL AND METHODS This study is a prospective clinical study and it was initiated after the approval of Karadeniz Technical University Faculty of Medicine Clinical Research Ethics Committee numbered 2017/88.

Between 2017-2019 years, pregnant women included in the study who admitted to the Department of Obstetrics and Gynecology at Karadeniz Technical University. The study was planned on cases who will undergo cesarean section over 34. week of gestation. They were not included in the study if pregnant women with pregestational or gestational diabetes mellitus, morbid obesity, thyroid dysfunction and fetal anomaly diagnosed aneuploidy or anomaly. Demographic data, ultrasonographic data and doppler parameters of all patients were recorded and evaluated prospectively. Informed consent was obtained from all participants prior to participation to work. Newborn results after birth were recorded.

Patients were divided into two groups. The study group consisted of late preterm cases (34-37 weeks of gestation) and the control group consisted of term cases (<37 weeks of gestation).

Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main research parameters. In both groups, fetal thorax and heart circumference ratio, mitral e/a wave ratio, right pulmonary artery and main pulmonary doppler indexes (PI, RI, S / D, AT / ET) were evaluated before cesarean section. All ultrasonographic examinations and measurements were performed by a single operator with color doppler ultrasonography device. Doppler measurements were performed in supine and slightly left-facing position. Doppler index measurements of two groups were recorded separately for each pregnant.

Lamellar Body Count Lamellar body counting; at least 2cc of amniotic fluid not infected with blood during the cesarean section was taken into the EDTA tube and not centrifuged in thestudy. The sample was studied by using automatic blood counting device which is used for counting the shaped elements of blood called Coulter Counter which makes automatic blood count in hematology laboratories. The value specified in the platelet count part was accepted as the number of lamellar bodies in the report.

Statistical analysis All data were analyzed using with IBM SPSS Statistics 11 (IBM SPSS, Turkey). In addition to descriptive statistical methods, Student's t test was used to compare the quantitative data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• preterm and term pregnancy

• caesarean cases

Exclusion Criteria:

• pregestational diabetes mellitus

• gestational diabetes mellitus

• morbid obesity

• thyroid dysfunction

• fetal anomaly diagnosed an euploidy or anomaly.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Prenatal Care Late
• Preterm Birth
• Preterm Labor

Intervention

Diagnostic Test:
• fetal heart doppler findings
Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main research parameters. In both groups, fetal thorax and heart circumference ratio, mitral e/a wave ratio, right pulmonary artery and main pulmonary doppler indexes (PI, RI, S / D, AT / ET) were evaluated before cesarean section.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lamellar body count	lamellar body count was higher in the control group	immediately after the procedure(1year)
Primary	Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio	this data was measured before cesarian section.significant/ nonsignificant differences were detected between groups	immediately after the procedure (1year)